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The purpose of the Health and Energy through Active Living Every Day (HEALED) intervention, is to examine the effect of a web-based intervention on changes in device-measured physical activity (light and moderate-to-vigorous intensity aerobic) and sedentary behavior. The purpose of this study is intended for survivors of a cancer with a 5-year survival (at Stage I, II, and III) of at least 45% that has a strong level of evidence for association with physical inactivity according to the 2018 PA Guidelines Advisory Committee Report (breast, colon, endometrium, kidney, bladder, multiple myeloma). In line with social cognitive theory behavior change techniques, participants will be provided information and skills necessary to be more physically active and less sedentary after a cancer diagnosis. New materials will be disseminated biweekly through a website open only to participants, and include at-home exercise demonstration videos, research news, discussion boards, success stories, infographics for exercise recommendations, etc.
By 2026, there will be approximately 20.3 million cancer survivors in the U.S., and this population is expected to grow with improved cancer survival rates. Cancer survivors experience a myriad of side effects following treatment, including fatigue, decreased muscle mass, balance issues, decreased cognitive function, and an increased risk of comorbidities. Observational studies and randomized controlled trials suggest that physical activity (PA) is a safe and effective non-pharmacologic option for improving some of these side effects. Despite the evidence, it is estimated that at least 75% of cancer survivors do not meet PA guidelines. Interventions tailored for survivors may increase PA, but there are gaps in the literature regarding the most effective methods. Further, there are several cancers associated with physical inactivity, but most PA interventions focus on breast cancer. Additionally, many existing interventions require in-person meetings, are very resource-intensive, and may not be sustainable. Most physical activity interventions focus on the promotion of moderate-vigorous PA, ignoring the importance of decreased sedentary time and increased light PA. Accordingly, it is imperative to create more sustainable, broad-reaching PA and sedentary behavior interventions that are intended for survivors of various physical inactivity-associated cancers. The proposed one-year study will be a two-arm, randomized control intervention embedded within the Cancer Prevention Study-3 (CPS-3), a prospective cohort study of cancer incidence and mortality initiated by the American Cancer Society. The proposed Health and Energy through Active Living Every Day (HEALED) intervention is intended for survivors of a cancer with an expected 5-year survival (at Stage I, II or III) of at least 45% that has a strong level of evidence for association with physical inactivity according to the 2018 PA Guidelines Advisory Committee Report (breast, colon, endometrium, kidney, multiple myeloma, and bladder). In line with social cognitive theory behavior change techniques, participants will be provided information and skills necessary to be more physically active and less sedentary after a cancer diagnosis. Materials and tools will be updated monthly through a secure website open only to participants, and include: at-home exercise demonstration videos, steps leaderboards, goal setting tools, Fitbit self-monitoring and syncing capabilities, discussion boards, success stories, infographics for exercise recommendations, etc. This intervention will add to the very minimal evidence base for PA interventions for diverse cancer survivors in a sustainable, broad-reaching manner. Further, the data resulting from this study will provide insight towards promotion of the "time-use" approach, which focuses on all of the movement behaviors (including sedentary time, light intensity physical activity, and moderate-to-vigorous physical activity), which has not yet been used in interventions for survivors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Activity Group | Experimental | Physical activity (PA) group participants will receive behavioral nudge e-mails with links to a web-based platform which will provide: physical activity information, at-home exercise demonstrations/videos for survivors of all fitness levels, articles, blog posts, physical activity/sitting recommendations, a space for goal setting, a platform for physical activity tracking, a discussion board, automatic syncing of their Fitbit to the leaderboard, etc. |
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| Balance and Flexibility Group | Active Comparator | The static Balance and Flexibility (BF) website will include infographics, videos, and articles for participants to view at their leisure. They will receive access to the HEALED website at the end of the 12-month intervention period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity experiment | Behavioral | The Physical Activity (PA) group will have access for one year to the PA website to help increase aerobic and strength training activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedentary time | Device-measured sedentary time with research-grade accelerometer | 12 months |
| Physical activity | Device-measured light, moderate, vigorous intensity physical activity with research-grade accelerometer and Fitbit. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Sleep Disturbance | 5-item questionnaire measuring self-reported alertness, sleepiness, tiredness, and functional impairments associated with sleep problems during waking hours within the past seven days. | 12 months |
| CPS-3 Fatigue Questions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Cancer Society (virtual recruitment and study) | Kennesaw | Georgia | 30144 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33954891 | Background | Rees-Punia E, Leach CR, Westmaas JL, Dempsey LF, Roberts AM, Nocera JR, Patel AV. Pilot Randomized Controlled Trial of Feasibility, Acceptability, and Preliminary Efficacy of a Web-Based Physical Activity and Sedentary Time Intervention for Survivors of Physical Inactivity-Related Cancers. Int J Behav Med. 2022 Apr;29(2):220-229. doi: 10.1007/s12529-021-09999-5. Epub 2021 May 6. | |
| 40461052 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 17, 2021 | Feb 1, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D005221 | Fatigue |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D009369 | Neoplasms |
| D009043 | Motor Activity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
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The intervention group will have access for one year to a website to help increase aerobic and strength training activities. The control group will have access for one year to a website to help improve balance and flexibility. At the end of the one-year study, each group will get access to the opposite website.
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Investigator will not be involved in randomization, but given the obvious differences in treatment vs. control, participants, investigator, and assessors will be aware of assignment.
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| Balance and flexibility control | Behavioral | The static Balance and Flexibility (BF) website will include infographics, videos, and articles for participants to view at their leisure around stretching and balance exercises. |
|
A 5-item Likert scale measuring fatigue, lack of energy and general tiredness within the past month.
| 12 months |
| PROMIS Global Mental and Physical Health | Instrument consists of ten global health items that represent five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). Four items are used to assess global physical health. Four items are used to assess global mental health, all of which are administered using five-category response scales. Higher scores indicate better mental/physical health. | 12 months |
| Emotional Distress-Anxiety | A PROMIS assessment of 8-items on the pure domain of anxiety in individuals age 18 and older. High scores indicate higher anxiety symptom severity. | 12 months |
| Emotional Distress-Depression | A PROMIS assessment of 7-items on the pure domain of depression in individuals age 18 and older. High scores indicate higher depression symptom severity. | 12 months |
| PROMIS Cognitive Function | This item bank assesses patient-perceived cognitive deficits. Facets include mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in cognitive functions. Higher scores indicate higher cognitive funciton. | 12 months |
| 30 second sit-stand test | Video-administered, self-reported sit-stand test (validity study: https://pubmed.ncbi.nlm.nih.gov/34797895/) | 12 months |
| Derived |
| Rees-Punia E, Masters M, Whalen S, Hartman SJ, Sullivan K, Westmaas JL, Teras LR, Patel AV. Digital intervention for increasing physical activity and reducing sedentary behaviour in cancer survivors: a trial within the Cancer Prevention Study-3 cohort. Br J Sports Med. 2025 Jul 31;59(16):1143-1150. doi: 10.1136/bjsports-2024-109332. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |